Ayurvedic medicines face EU ban from May 1

Published: Thursday, February 3, 2011, 17:30 [IST]

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Prasun Sonwalkar

London, Feb 3 (PTI) A ban on the sale of Ayurvedic andother herbal medicines will take effect across Europe from May1 following a European Union directive introduced as aresponse to growing concern over adverse effects of suchalternative medicines.

Users and promoters of such medicines have called theEU directive called The Traditional Herbal Medicinal ProductsDirective, 2004/24/EC, "discriminatory and disproportionate".

Ayurvedic and traditional herbal medicines will needto licensed to comply with the EU directive passed in 2004,which takes effect from May 1.

Official sources said those ayurvedic productsmarketed before the legislation came into force in 2004 cancontinue to market their product until April 30, 2011, underthe transitional measures.

Once this time limit has expired, all herbal medicinalproducts must have prior authorisation before they can bemarketed in the EU. Ayurvedic medicines such as "ashwagandha"will not be available for sale across Europe from May 1.

The directive aims to protect users from any damagingside-effects that can arise from taking unsuitable medicines.

The UK Medicines and Healthcare Products RegulatoryAgency (MHRA) has issued more than a dozen safety alerts inthe past two years, including one over aristolochia, a bannedtoxic plant derivative, which reportedly caused kidney failurein two women.

After the ban comes into effect, only high quality,long-established and scientifically safe herbal medicines willbe sold over the counter, official sources here said.

Herbal practitioners say it is impossible for mostherbal medicines to meet the licensing requirements for safetyand quality, which are intended to be similar to those forpharmaceutical drugs, because of the cost of testing.

According to the Alliance for Natural Health (ANH),which represents herbal practitioners, not a single productused in traditional Chinese medicine or ayurvedic medicine hasbeen licensed.

Producers and independent health store owners allegethat the directive draconian and favours large Europeanmanufacturers, but smaller firms will be in danger of beingsqueezed out of the market.

Under EU law, statutorily regulated herbalpractitioners will be permitted to continue prescribingunlicensed products, but the government in Britain has delayedplans to introduce a statutory herbal practitioner register.